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Our client are seeking a meticulous and proactive Quality Technician to join their team and ensure our processes meet regulatory requirements and industry standards.
Key Responsibilities:
Quality Management System:
* Issue controlled forms and logs.
* Manage review periods for controlled SOPs, ensuring timely reviews.
* Raise and implement change controls and assist with artwork change controls.
* Raise deviations and implement CAPAs.
* Maintain databases, files, and records.
* Assist with internal principle-based audits.
Release Process:
* Review batch documents and release batches, including physical release.
* Prepare Certificates of Analysis.
Equipment and Environment:
* Assist with temperature mapping as required.
* Arrange annual calibration and validations according to schedule.
* Maintain stability cabinets/HVAC and liaise with engineers/suppliers for maintenance and performance verification.
* Perform regular walkabouts of facilities, making recommendations for continued compliance.
Complaint Handling:
* Receive, log, and investigate complaints.
* Maintain a database and conduct trend analysis of complaints for monthly reports.
Miscellaneous:
* Assist with training where appropriate.
* Perform any other work reasonably required by the QA Manager or Company Directors.
General Duties:
* Report any health & safety or employment regulation transgressions immediately.
* Adhere to health & safety rules and procedures, including the use of applicable PPE.
* Follow relevant rules and procedures to ensure compliance with quality management systems.
Qualifications:
* Proven experience in quality assurance or a related field